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A Study Evaluating Safety and Tolerability of Switching From Semaglutide to Zovaglutide in Adults With Obesity (HORIZON-SWITCH-SZ)

ConditionObesity
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing QL Biopharmaceutical Co.,Ltd

About this trial

The main purpose of this study is to evaluate the safety and tolerability of continuing treatment with zovaglutide injection following titration to 2.4 mg semaglutide injection in adult participants with obesity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subjects aged≥18years and≤75 years at the time of signing the Informed Consent Form (ICF).

At screening, Body Mass Index (BMI)≥28kg/m²

Weight change due to diet and exercise alone within 3 months prior to screening did not exceed 5%.

Disqualifiers

Previously diagnosed obesity caused by monogenic mutations, other diseases, or medications.

Previous diagnosis of diabetes; or HbA1c ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L at screening.

Used of medicines or treatments that affect weight within 3 months prior to screening.

History of acute or chronic pancreatitis, or pancreatic injury.

Trial design

Design model

Parallel

Treatments tested in this trial

  • zovaglutide Arm 1

    Drug

    Zovaglutide will be administered via subcutaneous (SC) injection.

  • zovaglutide Arm 2

    Drug

    Zovaglutide will be administered via subcutaneous (SC) injection.

  • semaglutide

    Drug

    Semaglutide will be administered via subcutaneous (SC) injection.

Treatment groups

210 Participants
are divided into 3 treatment groups
Group A: zovaglutide Arm1Experimental treatment 1 intervention
Group B: zovaglutide Arm2Experimental treatment 1 intervention
Group C: semaglutide ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants achieving successful switch from semaglutide 2.4 mg to zovaglutide after randomization

Measure description:Definition of successful switch: Participants administered the target dose of assigned zovaglutide at both week28 and week32.

Time frame
from week 20 (randomization) to week 36

Secondary outcomes

1

Proportion of participants achieving successful switch without severe gastrointestinal adverse event (GIAE)

Time frame
from week 20 (randomization) to week 36
2

Proportion of participants achieving successful switch without dose modification

Time frame
from week 20 (randomization) to week 36
3

Incidence of GIAE

Time frame
from week 20 (randomization) to week 40
4

Percentage of GIAE-free duration relative to total period after randomization

Time frame
from week 20 (randomization) to week 40

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing QL Biopharmaceutical Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: